A Study of E7080 in Subjects With Solid Tumor

A Phase 1 Study of E7080 in Subjects With Solid Tumor

The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors

Inclusion Criteria

• Subjects with histologically and/or cytologically diagnosis of solid tumor
• Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
• Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
• Subjects who completed previous anti-tumor therapy before at least 4 weeks
• Subjects who are 20 years or older
• Subjects with 0 to 1 of Performance Status
• Subjects agree to be hospitalized for DLT observation
• Subjects with adequate organ functions
• Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration.
• Agree to participate in this study in writing based on voluntary will

Exclusion Criteria

• Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
• Subjects with the severe complication or disease history
• Subjects unable to take oral medication.
• Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
• Scheduled for surgery during the projected course of the study.
• Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.
• Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict
• Pregnant or nursing subjects
• Subjects who are participating in another clinical trial.